Ethics

To the Editor: We write regarding the study by Wilmott and colleagues1 and the accompanying editorial by McLaren and Mewett.2 There are data of interest in the study that are not found in the limited Victorian voluntary assisted dying (VAD) review reports. Notable is that four doctor participants had assessed more than 25 people each in the first year of VAD in Victoria. Given that 124 people died by VAD in the first year, the high caseload of a handful of participants highlights that few doctors choose to be VAD assessors. With a large proportion of assessments being carried out by only a strongly supportive few, this raises potential concerns about the independence of assessments, when the doctors who are the gatekeepers of VAD work together in small groups to determine eligibility. There is an association between clinicians willing to provide a hastened death (where this is legal) and advanced cancer patients in palliative care wanting just that.3 Some participants in the study acknowledged that VAD consultations via telehealth are a “second rate solution”.1 However, the legislative push for VAD telehealth assessments continues with an amendment currently before the Victorian parliament, even though this puts access ahead of safety, making it harder to exclude depression or coercion.4 It was useful to be reminded that Victorian guidelines prohibit the use of telehealth for VAD consultations due to federal criminal laws that ban suicide discussions on carriage services. However, it is known that some Victorian VAD consultations have already been conducted via telehealth.5 The editorialists state that evidence is needed to guide VAD practice that to date has been based on opinion and personal viewpoint.2 The evidence base to support the need for VAD should have been identified before and not after legalisation. Stories of distressing deaths reported by relatives can be misleading, especially when these conflict with published palliative care research that suggests excellent symptom control in dying Australians who can access and who accept specialist palliative care.6 While VAD as a new practice receives much attention, its availability does nothing to help the many thousands of Victorians each year who do not want assisted suicide but who struggle with unmet palliative care needs. Despite the time and money spent on VAD access, the palliative care needs of most Victorians at the end of life still remain largely unmet.7 Other Australian states and territories should be aware of this.

Marion T Harris · Maria C Cigolini

In reply

Lindy Willmott · Ben P White · Marcus Sellars

In reply

Cameron J McLaren · Greg Mewett

To the Editor: Close and colleagues raise some important issues in their article on voluntary assisted dying (VAD) and telehealth.1 For the most part, their four key considerations give good practical advice to clinicians trying to work around Commonwealth laws introduced for a substantially unrelated purpose. A scenario they do not address is where a patient has been assessed as eligible for VAD, and then needs to discuss with the doctor by telehealth the choice between having lethal medication administered to them, or taking it themself (self‐administration). This is already an issue in Western Australia, and will become an issue in Tasmania and Queensland; not so much in Victoria or South Australia, where this choice is essentially restricted by clinical criteria set out in the legislation. In the above scenario, it needs to be made clear to the patient that the doctor is not favouring self‐administration over practitioner administration, but has an open mind in talking through this choice by telehealth with the patient. Close and colleagues are right to caution against using telehealth to discuss the VAD medication protocol for self‐administration, but their advice to have such discussions in person is not particularly helpful when the doctor is remote from the patient. When self‐administration is chosen, Western Australian law requires written instructions to be provided to the patient by the doctor and the applicable pharmacist on how to prepare and take the lethal medication.2 It can be explained that these instructions will be provided as hard copy, with the doctor making clear that nothing said to the patient over telehealth should be construed as instruction on how to prepare or take the medication. When the pharmacist delivers the medication to the patient for self‐administration, as is the practice in Victoria and Western Australia, any question about the written instructions can be dealt with face to face, as part of the counselling of patients expected of pharmacists under guidelines issued by the Pharmacy Board of Australia.3

Richard SW Lugg

To the Editor: In March 2021, the federal Parliament introduced a bill to legalise the use of the reproductive technology known as mitochondrial donation in Australia.1 Mitochondrial donation would be offered initially at a single trial clinic and, eventually, it would be made more widely available. The aim is to provide at‐risk women with the opportunity to have a genetically related child who is unlikely to develop maternally inherited mitochondrial disease. Legalising mitochondrial donation would have meaningful benefits for such women. However, as the bill currently stands, its implementation raises unresolved ethical and legal issues. Access will predictably be mediated by geographic, financial, medical and informational considerations. These include the location of the initial trial clinic, any out‐of‐pocket costs to prospective parents, and health professionals’ awareness of mitochondrial donation. Existing barriers to genomic testing, genetic counselling, and assisted reproductive technologies will also affect access. These barriers, including long waiting times and limited Medicare coverage for some genetic services, should be minimised. Mitochondrial donation requires donor oocytes. This raises questions about how oocytes will be procured and how many should be apportioned to mitochondrial donation relative to other procedures that may require fewer eggs to achieve a live birth. One crucial issue is whether oocyte donation for mitochondrial donation should require specific consent from donors. One option is to use oocytes donated for assisted reproduction generally, without requiring consent for their use in mitochondrial donation specifically. The first study of mitochondrial donation to yield a live birth took this approach.2 However, we believe this strategy fails to acknowledge the legitimate reservations some donors may have about the use of their oocytes in this novel reproductive procedure. Securing specific informed consent would protect donors’ wellbeing and autonomy as well as protect public trust in medicine. At a minimum, specific consent should be required in the trial stage. This could also generate important data on the views of a critical group of stakeholders (the oocyte donors) and on what impact, if any, requiring specific consent would have on oocyte supply. Mitochondrial donation also prompts a reconsideration of the ethics of sex selection. The Australian Government has signalled that it may provide parents with the option of implanting only male embryos.3 Since mitochondrial DNA is inherited through the maternal line, this would minimise any effects on the descendants of children born via this technique. However, this use of sex selection sits uneasily with Australia’s legal prohibition on, and moral reservations regarding, non‐medical sex selection. Both male and female embryos would receive identical mitochondrial DNA and face the same risks from the procedure; sex selection reduces risks only to that child’s descendants. There is also a concern that offering sex selection would lead parents to believe it is medically indicated, creating a sense of pressure to select male embryos. As sex selection raises serious concerns without promising clear benefits, we think there are problems with offering it in this context. Legalising mitochondrial donation raises numerous ethical issues, including access, oocyte donor consent, and sex selection. While mitochondrial donation carries important potential benefits, these issues need careful attention to ensure that its implementation in Australia is ethically robust.

Julian Koplin · Esther Lestrell

To the Editor: “Patients often suggest a ‘social meeting’ after you have treated them. It’s a slippery slope” — quote from an Australian medical student.1 A review published in The Medical Journal of Australia of what constitutes misconduct in health professional–former patient sexual relationships highlights the variation between different health professional codes and the repercussions.2 The article notes the lack of national guidance or codes of conduct for health professional students regarding this or similar professional boundary issues.2 The lack of knowledge on this and other professionalism dilemmas faced by students led to the Professionalism Opinions of Medical Students (PoMS) study.1 We obtained ethics approval from the University of Western Australia (Ref. RA/4/1/9278) to conduct the PoMs study using a mixed methods approach with a validated online survey1 to triangulate how the Australian public (n = 503), qualified doctors (n = 809), and medical students (n = 2602) viewed a range of professionalism dilemmas that medical students may encounter. Participation was voluntary and anonymous. Medical students were informed about the study through their medical school. Doctors and the public were informed about the study using media and social media resources. The surveys were closed when recruitment had plateaued. One of the scenarios asked for respondents’ opinions on how acceptable it would be for a medical student to embark on a romantic relationship with a former patient, and if student participants had encountered a similar situation. To determine whether unconscious bias influenced participants’ opinions, there were two randomly administered versions with female or male protagonists (no same‐sex version was included). The scenario is described below: A male/female medical student bumps into a 25‐year‐old woman/man at an evening concert. The student had taken her/his history and performed an abdominal examination in the emergency department a fortnight ago when she/he had attended with abdominal pain. The pair get chatting and the woman/man invites the student back to her/his flat for “somewhere quieter for a drink”. The male/female student accepts the invitation. How acceptable is this student’s behaviour? Almost 4% of medical student respondents (n = 84) reported encountering a situation similar to the one described. Using the χ2 test to compare the responses, there were significant differences in how the three demographic groups viewed this scenario. Notably, more than 50% of the public (n = 237), compared with more than 37% of the students (n = 896) and 29% of the doctors (n = 215) who completed this section of the survey considered this behaviour as acceptable (P < 0.001), regardless of the gender of the protagonist. Doctor participants were the only group to have no gender bias for the acceptability of the protagonist’s behaviour. Medical students’ opinions were intermediate, but were significantly influenced by their stage in the course. Survey participants in the early years of the medical course expressed opinions that aligned more with the public’s responses (478/1099, 43%), but the responses of students in the later years of the course were closer to the views expressed by qualified doctors as to how acceptable they considered the behaviour to be (412/1195, 34%; P < 0.01), supporting the concept of professional identity formation. The PoMS results demonstrate that medical students encounter patient sexual relationship dilemmas and are often unsure about how to manage this — a situation compounded by a lack of national guidance or codes of conduct. We endorse the suggestion that governing bodies provide clearer guidance to health professionals,2 but also advocate that health professional students are provided with explicit guidance on this and on how to apply the other behavioural expectations of good medical practice3 as a student.

Paul M McGurgan · Katrina L Calvert · Christine M Jorm

To the Editor: The SAME study affirmed the safety and efficacy of switching between originator and biosimilars and the potential for cost savings.1 Yet the global uptake of biosimilars has been relatively slow2 due to a number of factors, including marketing suggesting that such drugs are less safe or efficacious than the originator.3 Implicated in such marketing is confusion arising from the use of the word “interchangeable”, which is a defined term under United States legislation. The word “substitution” is used in Australia, which raises the likelihood of further confusion. Pfizer, which sponsors both biologics and biosimilars, petitioned the US Food and Drug Administration to avoid false and misleading statements about biosimilars.3 Key to Pfizer’s arguments is the definition of “interchangeability” in the Biologics Price Competition and Innovation Act of 2009 (US). To establish interchangeability, further clinical data are needed to show that switching a patient back and forth between the reference product and biosimilar “can be expected to produce the same clinical result as the reference product in any given patient [and] … the risk in terms of safety or diminished efficacy of alternating or switching … is not greater than the risk of using the reference product without such alternation or switch” (§ 262(k)(4)). This represents a higher threshold than biosimilarity, and there are currently no approved interchangeable biosimilars in the US, although a Bill (HR 8190) is currently being considered by the US Congress on insulin products. In Australia, case law has accepted the Therapeutic Goods Administration definition of a biosimilar as “a version of an already registered biological medicine” having “similar characteristics” to the biologic, with no explicit statement as to what “similar” means.4 If the sponsor of the originator were to claim that a competitor biosimilar is not interchangeable, although this would be correct in a legal sense, such claims could be misunderstood by Australian audiences as meaning that it is less safe or not therapeutically equivalent, even when it is “a‐flagged” and approved for pharmacist substitution.5 Therefore, it is important to distinguish the use of “interchangeability” and “substitution”, as these terms may be understood differently by doctors, pharmacists, other health professionals, and patients. Describing a biosimilar as (only) “similar” obscures the reality that approved biosimilars are as safe and efficacious as the originator. In such circumstances, a switch is appropriate, especially if it will save the patient and Pharmaceutical Benefits Scheme considerable money.

David Lim · Rhiannon Bandiera · Elizabeth Handsley

In reply

Ashish Srinivasan · Craig Haifer · Lena Thin

In a critical year for climate action, two cases provide new pathways for climate litigation based on intergenerational impacts

Katherine Owens